Last April 1st, 2023, was issued an updated version of the MDSAP Audit approach applicable to all country members of the program: Therapeutic Goods Administration of Australia; Brazil’s Agência Nacional de Vigilância Sanitária of Brazil, Health Canada, Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency and The U.S. Food and Drug Administration
The guideline contains specific instructions for performing audits under the MDSAP program. It includes an audit sequence, instructions for auditing each specific process, and identifies links that highlight the interactions between the processes. The MDSAP audit sequence has four primary processes and two additional processes.
The MDSAP audit sequence was designed and developed to allow for the audit to be conducted in a logical, focused, and efficient manner. Then, information learned during the audit of one process will be used to make decisions about what to select for audit during the next process.
Remember that the MDSAP audit program is recognized by all Health Authorities in markets such as Australia, Brazil, Canada, Japan, and the USA. Therefore, if you are interested in fulfilling the MDSAP requirements and bringing your products to any or even all these markets, Osmunda can support you!